# K991024: Bone Bullet Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Nov 16, 1999 after 232 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930892 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953954: Preloaded Soft Tissue Anchor, Linvatec Corp. (1996) Summary page 3.
- K981764: LM Anchor, Li Medical Technologies, Inc. (1998) Summary page 3.

## Indications for use
The Bone Bullet Suture Anchor is used to attach soft tissue to bone for the following indications: Foot and Ankle 1. Hallux Valgus repairs 2. Midfoot reconstructions Elbow, Wrist and Hand 1. Scapholunate ligament reconstructions 2. Ulnar or radial collateral ligament reconstructions 3. PIP joint ligament reconstructions 4. Profundus tendon reattachment

Source page: https://510kreport.com/device/K991024
Methodology: https://510kreport.com/methodology